Needle assemblies

ABSTRACT

A needle assembly includes a needle with the needle having a handle at a proximal end portion thereof. The assembly also includes a guide tube sized to house the needle and handle, with the guide tube including an inwardly-extending projection adjacent a proximal end thereof. The inwardly-extending projection is configured to engage an engagement portion of the handle for retaining the needle within the guide tube such that a distal tip of the needle is positioned within the guide tube and a proximal end portion of the handle extends from the proximal end of the guide tube. The engagement being releasable upon a force applied to the proximal end portion of the handle to extend the distal tip of the needle out of the guide tube.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.16/993,932 filed on Aug. 14, 2020, which claims priority to and all thebenefits of U.S. Provisional Application No. 62/886,693 filed on Aug.14, 2019, the disclosures of which are expressly incorporated byreference in their entirety.

FIELD OF THE INVENTION

The invention relates to needle assemblies for acupuncture and dryneedling.

BACKGROUND OF THE INVENTION

Conventional needle assemblies for use in acupuncture and dry needlingtypically comprise a guide tube and a needle located within the guidetube. The needle has a handle which is secured via adhesive to theinside of the guide tube, to thereby retain the needle (specifically,the distal tip of the needle) within the guide tube. In use, thepractitioner applies the distal end of the guide tube to the patient'sskin (aligned with an acupuncture point or a pressure point), andapplies a force to the proximal end of the handle, eg by tapping, todisengage the needle from the guide tube, resulting in the distal tip ofthe needle penetrating the patient's skin.

However, the adhesive attaching the handle to the guide tube isconventionally single-use and loses its function once the handle hasbeen separated from the guide tube. Therefore, if the needle isinadvertently dislodged from the guide tube during packing, transport orstorage, it cannot be used (due to hygiene reasons) and has to bediscarded.

Further, there is also a challenge during manufacturing of conventionalneedle assemblies of applying a consistent amount of adhesive to eachneedle. A consistent predetermined amount is important, since excessiveadhesive affects the ease with which the practitioner dislodges theneedle from the guide tube, while insufficient adhesive results in alarger number of needles being inadvertently dislodged during transit orin storage.

In this context, there is a need for improved needle assemblies.

SUMMARY OF THE INVENTION

According to an aspect of the present invention, there is provided aneedle assembly comprising:

a needle having a handle at a proximal end portion thereof; and

a guide tube sized to house the needle and handle, the guide tubecomprising an inwardly-extending projection adjacent a proximal endthereof,

said inwardly-extending projection being configured to engage anengagement portion of the handle for retaining the needle within theguide tube such that a distal tip of the needle is positioned within theguide tube and a proximal end portion of the handle extends from theproximal end of the guide tube;

said engagement being releasable upon a force applied to a proximal endof the handle to extend the distal tip of the needle out of the guidetube.

The handle may be secured to the proximal end portion of the needle.

The engagement portion of the handle may comprise a textured anti-slipsurface.

The engagement portion of the handle may be etched to define thetextured anti-slip surface.

The engagement portion of the handle may be located intermediate distaland proximal end portions of the handle.

The guide tube may be manufactured of a translucent polymer.

The needle and handle may each be manufactured of a metallic material.

The needle may be manufactured of a stainless steel and the handle maybe manufactured of aluminum or an aluminum alloy.

In the engaged configuration, a distance between the inwardly-extendingprojection and a proximal end of the handle may be between about 5 mmand 8 mm.

A diameter of the handle may be between about 2 mm and 2.5 mm.

One or both of the proximal end portion and the distal end portion ofthe handle may comprise at least one indent for securing the needle tothe handle.

Following release of said engagement due to said force being applied tothe handle, said engagement may be reinstatable by repositioning theneedle such that the inwardly-extending projection re-engages theengagement portion.

In a further aspect, the present invention provides a method ofassembling a needle assembly described above, the method comprising:

inserting the proximal end portion of the needle into a central bore ofthe handle; and

inserting the needle and handle combination into the guide tube,

the handle being positioned such that the engagement portion of thehandle engages the inwardly-extending projection of the guide tube.

A diameter of the central bore of the handle may be between about 0.5 to1 time the diameter of the proximal end portion of the needle such thatthe needle is secured in the handle via interference fit.

The method may further comprise providing a plurality of bends in theproximal end portion of the needle prior to inserting the proximal endportion of the needle into the central bore of the handle.

The method may further comprise pressing the proximal and/or distal endportion(s) of the handle onto the needle to form said at least oneindent for securing the needle to the handle.

The inwardly-extending projection may be pressed into the guide tube toengage said engagement portion of the handle.

DESCRIPTION OF THE DRAWINGS

The invention will now be described, by way of non-limiting exampleonly, with reference to the accompanying drawings, in which:

FIG. 1 is a schematic illustration of a needle assembly according to oneembodiment;

FIG. 2 is a schematic illustration of a needle of the needle assembly;

FIG. 3 illustrates the needle assembly with needle extended;

FIG. 4 is a schematic illustration of the needle and handle of theneedle in a pre-assembled state;

FIG. 5 is a cross-sectional view of the handle of the needle; and

FIG. 6 illustrates packaged needle assemblies according to oneembodiment.

DETAILED DESCRIPTION

FIG. 1 illustrates a needle assembly 10 according to an embodiment ofthe present invention. The needle assembly 10 comprises a needle 21having a handle 22 secured to a proximal end portion of the needle 21and a guide tube 1 sized to house the needle and handle combination 2.The guide tube 1 comprises an inwardly-extending projection 11 adjacenta proximal end of the guide tube 1. The inwardly-extending projection 11is configured to engage an engagement portion 222 of the handle, forretaining the needle 21 within the guide tube 1 such that a distal tipof the needle 21 is positioned within the guide tube 1 and a proximalend portion of the handle 22 extends from the proximal end of the guidetube 1. This engaged configuration is illustrated in FIG. 1. Theengagement is releasable upon a force applied to a proximal end of thehandle 22 to extend the distal tip of the needle 21 out of the guidetube 1. This released configuration is illustrated in FIG. 3.

The inwardly-extending projection preferably extends inwardly to such anextent that when engaged with the engagement portion 222 of the handle,the opposite face of the handle abuts the internal wall of the guidetube 1.

The engagement portion 222 of the handle 22 comprises a texturedanti-slip surface. The roughness of the textured surface increases thecoefficient of friction between the engagement portion 222 and theinwardly-extending projection 11, resulting in a more secure engagementof the two components in the engaged state. In a preferred embodiment,the engagement portion 222 of the handle 22 is etched to define thetextured anti-slip surface. Alternatively, the textured anti-slipsurface may be formed by other methods, eg by cutting grooves,corrugations, notches, etc, into the engagement portion 222 of thehandle 2.

In yet other embodiments, the engagement portion 222 may compriseadditional or alternative surface modifications or finishes to increasethe coefficient of friction between the engagement portion 222 and theinwardly-extending projection 11, eg applying a tacky material to theengagement portion 222, adding ribs, embossing, etc.

In contrast with prior art needle assemblies, the engagement betweenguide tube 1 and the needle 22 is not via adhesive. As discussed above,a problem with the prior art adhesive engagement is that oncedisengaged, the needle cannot be securely repositioned in the engagedconfiguration. In comparison with such prior art assemblies, the needleassembly according to embodiments of the present invention isrepositionable. That is, following release of engagement between theinwardly-extending projection 11 and the engagement portion 222, theengagement is reinstatable by repositioning the needle such that theinwardly-extending projection 11 re-engages the engagement portion 222.Therefore, if the needle 21 is inadvertently dislodged from its engagedposition during packing, transit or storage, it may be repositionedwithin the guide tube 1 into the engaged/ready-to-use configuration,provided there has been no contamination of the distal tip of theneedle.

In the engaged configuration, the distance between theinwardly-extending projection 11 and the proximal end 30 of the handle(ie the distance L1 plus L2) is between about 5 mm and 8 mm. In thereleased configuration, the extension of the distal tip of the needlefrom the distal end of the guide tube (ie the distance L0) is betweenabout 5 mm and 8 mm.

The handle 22 may be circular in cross-section, with a diameter of thehandle 22 between about 2 mm and 2.5 mm. It is envisaged that such adiameter facilitates handling of the needle.

As illustrated most clearly in FIG. 2, the engagement portion 222 of thehandle is located intermediate distal 221 and proximal 223 end portionsof the handle 22. One or both of the proximal end portion 221 and thedistal end portion 223 of the handle may comprise at least oneinwardly-extending projection or indent for securing the needle 21 tothe handle 22. For example, three inwardly-extending projections 224,spaced around the circumference of the handle may be formed in thedistal end portion 221 to secure the needle 21 in the handle 22.Additionally or alternatively, two indents 225 may be provided, axiallyspaced from each other, in the proximal end portion 223 of the handle tosecure the needle 21 in the handle 22.

Additionally or alternatively, the needle is secured within the handlevia interference fit. With reference to FIGS. 4 and 5, the handle 22comprises a central axially-extending bore 40 configured to receive theproximal end portion of the needle 21. The diameter of the central boremay be between about 0.5 to one time the diameter of the proximal endportion of the needle, such that the needle, once inserted into thehandle, is fixed therein via friction/interference fit.

Additionally or alternatively, the proximal end portion of the needlemay be provided with a plurality of kinks or bends 50 such that theproximal end portion diverges from linear. When the needle is forcedinto the linear bore 40 of the handle, the bent portion of the needle isforced into a linear configuration that is resisted by the elasticity ofthe needle, which helps to secure the needle in the handle.

The guide tube 1 is preferably manufactured of a transparent ortranslucent polymer. In a preferred embodiment, the guide tube is formedby injection molding. Alternative processing methods may also besuitable, such as plastics extrusion. The proximal and distal ends ofthe guide tube 1 preferably comprise smooth surfaces to preventscratching of the skin in use.

The needle 21 is preferably manufactured of a metallic material, forflexibility of the needle and ease of sterilisation. For example, theneedle may be manufactured of a stainless steel.

The handle 22 is preferably manufactured of a metallic material, forexample, aluminum or an aluminum alloy.

The present invention also relates to methods of making and assemblingneedle assembly 10.

In one embodiment, the assembly method comprises inserting the proximalend portion of the needle 21 into the central bore 40 of the handle 22,inserting the needle and handle combination 2 into the guide tube 1, thehandle being positioned such that the engagement portion 222 of thehandle engages the inwardly-extending projection 11 of the guide tube.

In one example, prior to insertion of the needle 21 into the handle 22,the proximal end portion of the needle is crimped or otherwise shaped toform the plurality of kinks/bends 50. The needle 21 is then pulledthrough the bore 40 of the handle 22 such that the kinks/bends 50 arepositioned within the handle 22. In some embodiments, the diameter ofthe bore 40 is less than the diameter of the proximal end portion of theneedle, so that the needle is secured within the handle via interferencefit. The distal end of the needle may then be sharpened to a suitabletip. In other examples, the sharp distal tip of the needle is formedprior to insertion of the needle into the handle.

In some embodiments, once the needle 21 has been inserted into thehandle 22, the proximal end portion 221 and/or the distal end portion223 is/are pressed to form the projection(s) 224 and/or indent(s) 225that help to secure the needle to the handle.

The engagement portion 222 of the handle is preferably formed, eg viaetching as discussed above, before the needle 21 is inserted into thehandle, to reduce the risk of contaminating the distal tip of the needleduring such processing. However, the engagement portion 222 couldconceivably alternatively be formed on the handle portion during orafter insertion of the needle into the handle.

In one embodiment, the inwardly-extending projection 11 is formed afterthe needle and handle combination 2 has been inserted into the guidetube 1. For example, the proximal end portion of the guide tube 1 may becrimped, pressed or stamped to form the inwardly-extending projection11.

The needle assembly 10 may be packaged for distribution, eg in sterileblister packs 70 as illustrated in FIG. 6. The engagement between theinwardly-extending projection 11 and the engagement portion 222 of thehandle is typically sufficient to retain the distal tip of the needlehygienically within the guide tube until the user/practitioner is readyto use the needle assembly 10. However, in the unlikely event that theneedle 21 is dislodged out of the guide tube 1 during transit or storageof the packaged needle assemblies, for example as indicated by reference60 in FIG. 6, the practitioner may, prior to use, carefully reinsert theneedle into the guide tube, re-establishing the engagement between theinwardly-extending projection 11 and the engagement portion 222 of thehandle, as long as the distal tip of the needle has not beentouched/contaminated. Accordingly, the reinstatable nature of needleassembly 10 reduces wastage.

To use the needle, the practitioner removes the needle assembly 10 fromthe packaging, applies the distal end of the guide tube 1 to thepatient's skin, and applies a force on the proximal end of the handle 22(eg by tapping) to insert the needle into the patient's skin. Once theengagement between the inwardly-extending projection 11 and theengagement portion 222 has been released (by the force applied to theproximal end of the handle 22), the needle slides smoothly along theguide tube to extend out of the distal end thereof (ie there are nofurther disruptions to the movement of the needle within the guidetube).

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not by way of limitation. It will be apparent to aperson skilled in the relevant art that various changes in form anddetail can be made therein without departing from the spirit and scopeof the invention. Thus, the present invention should not be limited byany of the above described exemplary embodiments.

The reference in this specification to any prior publication (orinformation derived from it), or to any matter which is known, is not,and should not be taken as an acknowledgment or admission or any form ofsuggestion that that prior publication (or information derived from it)or known matter forms part of the common general knowledge in the fieldof endeavor to which this specification relates.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising”, will be understood to imply the inclusionof a stated integer or step or group of integers or steps but not theexclusion of any other integer or step or group of integers or steps.

What is claimed is:
 1. A needle assembly comprising: a needle having ahandle at a proximal end portion thereof; and a guide tube sized tohouse the needle and handle, the guide tube comprising aninwardly-extending projection adjacent a proximal end thereof, whereinthe inwardly-extending projection is configured to engage an engagementportion of the handle for retaining the needle within the guide tubesuch that a distal tip of the needle is positioned within the guide tubeand a proximal end portion of the handle extends from the proximal endof the guide tube; and wherein the engagement being releasable upon aforce applied to the proximal end of the handle to extend the distal tipof the needle out of the guide tube.
 2. The needle assembly of claim 1,wherein the handle is secured to the proximal end portion of the needle.3. The needle assembly of claim 1, wherein the engagement portion of thehandle comprises a textured anti-slip surface.
 4. The needle assembly ofclaim 3, wherein the engagement portion of the handle is etched todefine the textured anti-slip surface.
 5. The needle assembly of claim1, wherein the engagement portion of the handle is located intermediatedistal and proximal end portions of the handle.
 6. The needle assemblyof claim 1, wherein the guide tube is manufactured of a translucentpolymer.
 7. The needle assembly of claim 1, wherein the needle andhandle are metallic.
 8. The needle assembly of claim 7, wherein theneedle is manufactured of a stainless steel and the handle ismanufactured of aluminum or an aluminum alloy.
 9. The needle assembly ofclaim 1, wherein, in the engaged configuration, a distance between theinwardly-extending projection and a proximal end of the handle isbetween about 5 mm and 8 mm.
 10. The needle assembly of claim 1, whereina diameter of the handle is between about 2 mm and 2.5 mm.
 11. Theneedle assembly of claim 1, wherein one or both of the proximal endportion and a distal end portion of the handle comprises at least oneindent for securing the needle to the handle.
 12. The needle assembly ofclaim 1, wherein following release of the engagement due to the forcebeing applied to the handle, the engagement is reinstatable byrepositioning the needle such that the inwardly-extending projectionre-engages the engagement portion.
 13. The needle assembly of claim 2,wherein the engagement portion of the handle comprises a texturedanti-slip surface and is located intermediate distal and proximal endportions of the handle.
 14. The needle assembly of claim 13, wherein theguide tube comprises a translucent polymer, the needle comprisesstainless steel, and the handle comprises aluminum or an aluminum alloy.15. The needle assembly of claim 9, wherein a diameter of the handle isbetween about 2 mm and 2.5 mm, and wherein one or both of the proximalend portion and the distal end portion of the handle comprises at leastone indent for securing the needle to the handle.
 16. A method ofassembling a needle assembly comprising: providing a needle having ahandle at a proximal end portion thereof, with the handle having acentral bore and an engagement portion; providing a guide tube sized tohouse the needle and handle, the guide tube comprising aninwardly-extending projection adjacent a proximal end thereof, insertingthe proximal end portion of the needle into the central bore of thehandle; and inserting the needle and handle combination into the guidetube, wherein the handle is positioned such that the engagement portionof the handle engages the inwardly-extending projection of the guidetube for retaining the needle within the guide tube such that a distaltip of the needle is positioned within the guide tube and the handle atthe proximal end portion extends from the proximal end of the guidetube; and wherein the engagement is releasable upon a force applied tothe proximal end of the handle to extend the distal tip of the needleout of the guide tube.
 17. The method of claim 16, wherein a diameter ofthe central bore of the handle is between about 0.5 to 1 time thediameter of the proximal end portion of the needle such that the needleis secured in the handle via interference fit.
 18. The method of claim16, further comprising providing a plurality of bends in the proximalend portion of the needle prior to inserting the proximal end portion ofthe needle into the central bore of the handle.
 19. The method of claim16, further comprising pressing the proximal and/or distal endportion(s) of the handle onto the needle to form at least one indent forsecuring the needle to the handle.
 20. The method of claim 16, whereinthe inwardly-extending projection is pressed into the guide tube toengage the engagement portion of the handle.
 21. A needle assemblycomprising: a needle having a handle secured at a proximal end portionof the needle; and a guide tube formed from a translucent polymer andsized to house the needle and handle, the guide tube comprising aninwardly-extending projection adjacent a proximal end thereof, whereinthe inwardly-extending projection is configured to engage an engagementportion of the handle for retaining the needle within the guide tubesuch that a distal tip of the needle is positioned within the guide tubeand a proximal end portion of the handle extends from the proximal endof the guide tube; wherein the engagement being releasable upon a forceapplied to the proximal end of the handle to extend the distal tip ofthe needle out of the guide tube, and wherein the engagement portion ofthe handle comprises a textured anti-slip surface etched into thehandle; and wherein the engagement portion of the handle is locatedintermediate distal and proximal end portions of the handle.